WASHINGTON Democrats irritated by a recent Supreme Court decision shielding medical device companies from state liability lawsuits plan to unveil legislation to reverse the ruling, the first of many expected efforts to chop away at federal rules that restrict consumers’ ability to sue, according to published reports.

House Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., and House Oversight and Government Reform Chairman Henry Waxman, D-Calif., will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients’ ability to seek damages under state law, a Pallone spokesman said.

The two were spurred to act after the Supreme Court ruled in February that patients injured by defective medical devices can not sue for damages in state courts if the FDA approved the marketing of the product.

The justices found that the 1976 Medical Device Amendments pre-empted the right of injured patients to sue for damages in state courts against the most complicated or high-risk devices that undergo FDA’s strictest approval process. Justices are in various stages of weighing pharmaceutical pre-emption cases.

Antibody drug found cost-effective against allergic asthma

NEW YORK A review of seven studies has found the antibody drug Xolair to be cost-effective in treating allergic asthma, according to a report published in the journal Allergy.

The report, by University of Washington researcher Sean Sullivan and Dr. F. Turk of Novartis Pharma showed that Xolair, Novartis’ brand name for omalizumab, showed the drug was cost-effective in treating allergic asthma for which common asthma medications were inadequate.

The studies also found some evidence that Xolair may not be as cost-effective in treating other forms of asthma.

Novartis and Genentech market Xolair in the U.S. Genentech reported U.S. sales of $472 million for the drug in 2007, according to Novartis financial data.

First DataBank settles lawsuit for $1 million

BOSTON First DataBank, a provider of integrated databases of information about medications, has agreed to pay $1 million to settle a lawsuit alleging it conspired with McKesson to manipulate the average wholesale price of drugs.

The case, New England Carpenters Health Benefits Fund vs. First DataBank, filed in 2005, alleges that First DataBank and McKesson “wrongfully increased the so-called wholesale acquisition cost to AWP markup factor applied to numerous prescription pharmaceuticals through a scheme begun in late 2001 and 2002,” which meant that the plaintiffs in the class action lawsuit made “substantial excess payments.”

First DataBank denies any wrongdoing or liability and “has valid and complete defenses to the claims asserted against [it] in the class action,” which it is settling to avoid the expense and inconvenience of further litigation, the settlement says.

The case, filed in the U.S. District Court for the District of Massachusetts, explicitly excludes government entities from joining the class action suit. The San Francisco Health Plan and the state of Connecticut have filed suits with similar charges that McKesson and First DataBank inflated the spread between WAC and AWP from 20 percent to 25 percent, costing state Medicaid and other health programs untold sums.

First DataBank is not named as a defendant in the two new lawsuits. McKesson continues to defend itself in all three cases.

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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